Regulatory Affairs Specialist

Location
Leicester
Salary
Up to £33,000 per annum + 28 days holiday (inc BH), pension and childcare voucher scheme
Posted
12 Jun 2018
Closes
10 Jul 2018
Ref
RAS
Contract Type
Permanent
Hours
Full Time

Are you looking to join an award-winning pharmaceutical company? Morningside Healthcare Ltd are excited to announce that we are currently looking to recruit a Regulatory Affairs Specialist to join our team in our new modern offices.

Duties and Responsibilities (including but not limited to):

  • Experience in Formulation Regulatory, specifically in the EU applications MRP/DCP
  • Quality review in CTD / eCTD format as per EU guidelines
  • Compilation of dossiers for EU timely submission
  • Close interaction with query response and coordination
  • Formulating regulatory strategy for filing various products in the EU
  • Compliance from regulatory point of view for audits and response.
  • Strategic planning and execution of the International Regulatory Audits ( MHRA and other EU agencies)
  • Experience in Quality Systems and implementation
  • Provide the Project teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning
  • Implement QA systems and generate SOPs
  • Close interaction with contract manufacturers both in and outside the EU
  • Familiarity with readability testing would be helpful.

Background requirements;

  • Ability to work both independently and within a team structure;
  • Proven ability to lead, influence and motivate colleagues and external partners;
  • Good knowledge of guidelines from EMEA
  • Good knowledge on tech transfer
  • Strong planning, presentation and interpersonal skills;
  • Strong work ethic, self-motivation, dedication and results orientation;
  • Significant working knowledge of the pharmaceutical product development process (e.g., regulatory requirements, GMP, clinical strategies, drug delivery etc.);
  • Understanding of the role of drug delivery in the pharmaceutical marketplace, in both scientific and business context (e.g., market exclusivity requirements, role of IP in life cycle management is a plus.
  • Possession of first rate written and verbal communication skills.
  • Demonstrate good working knowledge of IT systems.
  • Ability to work to strict deadlines under pressure.
  • Extensive Relevant Regulatory Affairs experience
  • A strong technical background educated to degree level (or equivalent) in one of the life sciences.

Benefits include;

28 days holiday (including public holidays)

Training and development

Staff discount Childcare voucher scheme

Pension

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